FOR IMMEDIATE RELEASE
Protocol Design, CDISC, Regulatory Challenges and Late-Phase Trials Top Agenda at DIA Japan Conference and Webinar
NEW YORK, NY – December 17, 2008 – Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced that its top executives will present at the Drug Information Association’s (DIA) Japan conference and participate in a DIA-led webinar in January:
DIA Japan 12th Annual Workshop in Japan for Clinical Data Management
January 29-30, 2009, Tokyo, Japan
DIA Japan’s 12th Annual Workshop in Japan for Clinical Data Management brings together professionals from the biopharmaceutical industry, contract service organizations, academic research centers and regulatory agencies to cover a variety of topics, including best practices in data management, quality control and new technology. Global studies and Japan’s role in clinical data management will be the main themes of the conference.
Speaker: Glen de Vries, President
Session Title: “Structured Protocol Design and the Data Manager”
Date & Time: Thursday, January 29, 3:30 PM
This session will examine the origins of structured protocol design and the current state of the art. Glen will illustrate the unique benefits that a structured protocol document can provide from the perspectives of study planning, retrospective analysis of trial performance metrics, and prospective management of data management resources. He will also review possible roles of structured protocol design in the future role of clinical development, and specifically the future of data management.
Speaker: Fran Nolan, Vice President, Global Quality Assurance
Session Title: “Challenges for Non-Japanese Companies in Meeting Japan's Regulatory Requirements”
Date & Time: Friday, January 30, 10:30 AM
Fran will discuss the challenges faced by non-Japanese companies in meeting the country’s regulatory requirements and how these companies would benefit from understanding these requirements, as well as the related Japanese priorities and perspectives. Fran will review these key areas, requirements, priorities and perspectives, and offer ideas on how to overcome the associated challenges.
Speaker: Andrew Newbigging, Vice President, Integrations Development
Session Title: “Using CDISC Standards to Optimize the eClinical Process”
Date & Time: Friday, January 29, 3:00 PM
Andrew’s presentation will describe how clinical trial application tools built on the CDISC Operational Data Model (ODM) standard can automate data transfer processes across disparate systems – without resource-intensive tasks such as custom development and validation – moving sponsors closer to a user-controlled environment for data integration. This approach’s standard integration components eliminate the need for custom development and leverages CDISC standards to resolve the system “communication gap.”
DIA Webinar: Electronic Data Capture: Strategies to Enhance Data Capture, Satisfaction and Participation in Registries and Observational Studies
Speaker: Patrick Chassaigne, Director, Late Phase Solutions
Date & Time: January 14, 2009, 11:00 AM
In a webinar hosted by DIA, Patrick will join Cheryl Moore from Georgia Cancer Specialists and Eunice Franklin-Becker of Covance in a discussion about planning a late phase study using electronic data capture (EDC). The webinar will offer perspectives from the site, CRO and technology vendor about best practices for EDC implementations in registries and observational studies. Patrick will examine the challenges of late phase studies and how EDC capabilities can address them, particularly in supporting site recruitment, retention and satisfaction. Register at
http://www.diahome.org/DIAHOME/Education/MeetingEventRegistration.aspx.
For background information about Medidata executives, please visit http://www.mdsol.com/about/team_management.htm.
About Medidata Solutions Worldwide
Medidata Solutions helps the world’s leading pharmaceutical, biotechnology, medical device and research organizations maximize the value of their clinical research investments. Innovative process design, technology and services streamline clinical trials by providing early visibility to reliable clinical data – the lifeblood of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market – on six continents and in more than 80 countries. Medidata Solutions brings significant value to its broad client base with deep clinical experience and expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. For more information, please visit www.mdsol.com.
Contact:
Susan McCarron
Lois Paul & Partners
781.782.5767
Susan_McCarron@lpp.com